Posted by Michael Wonder on 17 Nov 2018
Highlights from CHMP 12-15 November 2018 meeting
16 November 2018 - The EMA’s CHMP has recommended four medicines for approval, including a medicine for use in countries outside the European Union, at its November 2018 meeting.
The CHMP adopted a positive opinion for Fexinidazole Winthrop (fexinidazole), the first oral-only medicine (tablets) for the treatment of human African trypanosomiasis, commonly known as sleeping sickness, due to Trypanosoma brucei gambiense.
Erleada (apalutamide) received a positive opinion for the treatment of non-metastatic castration resistant prostate cancer.
The CHMP recommended granting a marketing authorisation for Macimorelin Aeterna Zentaris (macimorelin), for the diagnosis of growth hormone deficiency in adults.
The generic medicine Silodosin Recordati (silodosin) received a positive opinion from the CHMP for the treatment of the signs and symptoms of benign prostatic hyperplasia.
